WHO Drug Information Vol. 18, No. 2, 2004 - World Health ...

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WHO Drug Information Vol 18, No. 2, 2004 with caution in these patients, particularly at higher doses, as the risk of myopathy increases with higher drug levels. Healthcare professionals are reminded of the following key safety messages: start doses and maintenance doses of drug should be based on individual cholesterol goals and apparent risks for side-effects; all patients should be informed that statins can cause muscle injury, which in rare, severe cases, can cause kidney damage and other organ failure that are potentially lifethreatening; and patients should be told to promptly report to their physician signs or symptoms of muscle pain and weakness, malaise, fever, dark urine, nausea, or vomiting. The current FDA-approved label can be obtained at http:// www.fda.gov/cder/foi/label/2003/ 21366_crestor_lbl.pdf Reference: FDA Public Health Advisory, 9 June 2004. Sulphur hexafluoride: contraindicated in heart disease European Union — Severe allergy and heart problems have been reported as rare side effects occurring within minutes of of sulphur hexafluoride administration (Sonovue®), a diagnostic contrast medium for use with ultrasound imaging where study without contrast enhancement is inconclusive. As such, it is only used in the hospital or clinical setting. On the basis of reported adverse events and as a precautionary measure, the European Medicines Agency has restricted use by a temporary suspension in heart imaging pending further evaluation. Sulphur hexafluoride is now contraindicated in patients with known coronary artery disease, myocardial infarction, unstable angina, acute cardiac failure, class II/IV cardiac failure, severe rhythm disorders, acute endocarditis and prosthetic valves. Patients should be kept under close medical supervision during and for at least 30 minutes following administration of sulphur hexafluoride. Adverse events included severe hypotension, bradycardia, cardiac arrest and acute myocardial infarction, in the context of an idosyncratic hypersensitivity reaction. Reference: EMEA Public statement. 19 May 2004 on http://www.emea.eu.int Oxandrolone and warfarin Regulatory and Safety Action United States of America — The manufacturer of oxandrolone (Oxandrin®) has provided new safety information when used concurrently with the oral anticoagulant warfarin for systemic anticoagulation. Oxandrolone, a synthetic derivative of testosterone, is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis. As a class, anabolic androgenic steroids may increase susceptibility, specifically to oral anticoagulants, with reduction of the anticoagulant dosage necessary to maintain the desired prothrombin time (PT). No specific directions have previously been available for any anabolic androgenic agents. A recent clinical study conducted by Savient demonstrated a significant decrease (80–85%) in the warfarin dose needed to achieve therapeutic effect in subjects also treated with oxandrolone. The recommendations are specific and cannot be presumed to be applicable for other anabolic androgenic steroids. Concurrent dosing of oxandrolone and warfarin may result in unexpectedly large increases in the International Normalized Ratio (INR) or PT. When oxandrolone is prescribed to patients being treated with warfarin, doses of warfarin may need to be decreased significantly to maintain a desirable INR level and diminish the risk of potentially serious bleeding. Physicians should instruct patients to report immediately any use of warfarin and any bleeding. Furthermore, in patients receiving both drugs, careful monitoring of the INR or PT, and adjustment of the warfarin dosage if indicated, are recommended when the oxandrolone dose is changed or discontinued. Patients should be closely monitored for signs and symptoms of occult bleeding. Reference: FDA Safety Alert: 20 April 2004 at http:// www.fda.gov/medwatch/index.html. Oseltamivir: new preclinical findings Singapore — Oseltamivir (Tamiflu®, Roche) was recently licensed for the treatment of uncomplicated illness due to influenza infections in children 131
Regulatory and Safety Action one year of age and older who have been symptomatic for no more than 2 days. It has been licensed for use in adults since October 2000. The findings of a recent preclinical study alerts potential concerns pertaining to the use of Tamiflu® in very young children. The manufacturer has recently released findings of its preclinical study carried out in juvenile rats (7-day old) and highlighted the concerns to the regulatory authorities regarding the use of Tamiflu® in infants. Juvenile rats that were treated with a single dose of 1000 mg/kg oseltamivir (about 250 times the recommended total daily dose) died due to the unusually high levels of oseltamivir and its phosphate salt found in the brain of these young animals. The concentrations of oseltamivir phosphate were approximately 1500 times those seen in adult rats given the same dose. It is likely that these high exposures are related to an immature blood brain barrier of the juvenile rats. Studies showed no death or other significant effects in older juvenile rats given the same or higher doses of Tamiflu®. HSA’s recommendation The clinical significance of these data to human infants is uncertain. Due to the uncertainty in predicting the exposures in infants with immature blood brain barrier, prescribers are advised that Tamiflu® should not be given to children under 1 year of age. The above findings have been included in the package insert of Tamiflu®. Reference: Product safety alerts, 15 March 2004. Health Sciences Authority, Singapore on http:// www.hsa.gov.sg Muromonab: nervous system complications Canada — The manufacturer of muromonab-CD3 (Orthoclone OKT*3®) has informed Canadian hospitals of important new safety information. Muromonab is used to treat acute rejection from liver, kidney, and heart transplants that do not respond to other therapies. Muromonab is not approved for use in children in Canada. Children treated with muromonab may be at increased risk of nervous system complica- 132 WHO Drug Information Vol 18, No. 2, 2004 tions, most notably a buildup of excess fluid in the brain (cerebral oedema) that may result in a fatal condition called cerebral herniation. Children may also be at increased risk of lymphomas and infections. Since 1986, a total of nine (9) cases of cerebral oedema have been reported around the world in children, with subsequent cerebral herniation and death in 6 of the 9 cases. The majority of the cases of cerebral herniation in paediatric patients occurred within a few hours to one day after the first injection. Signs of cerebral oedema and cerebral herniation may include the sudden appearance of severe headache, seizures, impaired mental function, drowsiness and lethargy, coma. Patients with high blood pressure and excess fluid buildup in their bodies (fluid overload) are at increased risk of developing these conditions. Reference: Communication from manufacturer on http:// www.hc-sc.gc.ca dated 17 May 2004. Domperidone and unapproved use United States of America — In response to reports that women may be using an unapproved drug, domperidone, to increase milk production (lactation), the Food and Drug Administration (FDA) is warning breastfeeding women not to use this product because of safety concerns. The FDA has also issued six letters to pharmacies that compound products containing domperidone and firms that supply domperidone for use in compounding. FDA has become aware that some women are purchasing domperidone to increase breast milk production. Domperidone may increase the secretion of prolactin, a hormone that is needed for lactation. The potential public health risks associated with domperidone include cardiac arrhythmias, cardiac arrest, and sudden death in patients receiving an intravenous form of domperidone. The oral form of domperidone by breastfeeding women can expose a breastfeeding infant to unknown risks. Domperidone is not approved in the USA for any indication. Reference: FDA Talk paper, T04–17, 2004.
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